Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1698942234459.pdf (Uganda)
I HARMONISED AMENDMENTS TO THE NATIONAL BIO.

SAFETY BILL AS RETURNED BY H.E THE PRESIDENT.

1.

Clause 1.

Application.

Replace sub clause (1) with the following; (1) This Act shall apply to the genetic engineering of organisms for agriculture and related applications and products therefrom.
Replace sub clause (2) as follows; (2)For the avoidance of doubt, this Act shall not apply to - (a) genetic engineering of organisms intended for human pharmaceutical use and which are the subject of any other law; and (b) human-cloning.

Justification To restrict the scope of genetic engineering to plants and animals i.e agricultural products that is targeted for regulation by the proposed law.

2.

Clause 2.
2.

Clause 2.

Objectives Substitute for the words "modern biotechnology" appearing in paragraph (b) and wherever it appears in the bi!

!, with the words "genetic engineering" Justification Consequential amendment having dropped reference to the term "modern biotechnology".

1, I 3.
1, I 3.

Clause 3. lnterpretation i. insert the following new definitions; "a national indigenous gene bank" means any genetic resource centre established under any law for the purposes of conservation of indigenous varieties of plants and animals.

"Benefit shoring" means the shoring of financial or other benefits that accrue from the utilization of indigenous genetic resources developed by any individual, group or community.
"Council" means the National Genetic Engineering Council established under section 6' "Genetic Engineering" means the application of; (a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into ce!

!s or organelles; (b) fusion of cells beyond the taxonomic family, thot overcome natura!

physiological reproductive or recombination barriers and thot ore not techniques used in traditional breeding or selection.
"inspector" means any person appointed as on inspector under this Act; 2 a "person" includes any individual, company, association, or body of persons corporate or unincorporated; "safety and risk assessment" means an evaluation of any direct or indirect, short, medium and Iong term risk to human or animal health, the environment, biological diversity and to the socioeconomic conditions or ethical values of the people of Uganda arising from the import, transit, contained use, release or placing on the market of a genetically engineered material; Justification (a)To give clear interpretation of key terms used in the bill (b) The above definitions are intelligible and simple for the public for whom Parliament legislates.
(c) There is no centralized national indigenous bank but rather genetic resource centres established under various Iaws like the Animals Breeding Act, 2001 created the National Animal Genetic Resource Centre.

ii.

Substitute "Genetically Engineered Organism" with "Genetically Engineered Material" and define as follows; "genetically engineered material" means an organism or material produced through genetic engineering.

iii.

Replace "GMO" with "GEM" everywhere it appears in the Bill.
Justification Genetically engineered material (GEM) includes both the organisms and products of genetic engineering.

3 I 4.

Clause 6.

Establishment of the Council.

Replace clause 6 as follows; (1)There is established a Council to be known as "the National Genetic Engineering Council" (2)The Council is designated as the Competent Authority for genetic engineering under this Act.

(3)The Council shall be a body corporate with perpetual succession, a common seal and shal!
be capable of suing and being sued in its corporate name and do all things a body corporate may laMully do.

(a)The application of the seal of the Council on any document shal!

be authenticated by the signatures of the Chairperson of the Governing Council and the Executive Director.
(5)ln the absence of the Chairperson, a member of the Governing Council performing the functions of the Chairperson may sign in his or her place; and in the absence of the Executive Director, a person performing the functions of the Executive Director may sign in his or her place.

(6)Every document purporting to be an instrument issued by the Council, shall be sealed with the seal of the Council and authenticated in accordance with subsection (4) or (5) sha!!

be deemed to be an instrument of the Council.


(7)The Council shall be domiciled in a ministry as may be directed by the President.

4 f (8)The Arlinister may give directions in writing to the Council with respect to the policy to be obserued and implemented by the Council.

(9)A Direction given by the Arlinister under subsecfion (8) shall not adversely affect or interfere with the independence of the Council or the performance of the functions and exercise of the powers of the Council under the Act.
(10) The direction given to the Council by the Arlinister under sub secfion (8) shall come into force upon publication in the Gazette Justification This is in line with the proposal by the President to administratively determine the Government Department to house the Competent Authority.

5.

Clause 7.
5.

Clause 7.

Functions of the Competent Authority Amend sub Clause (1) by adding a new paragraph (s) immediately after paragraph (r) to read as follows: (s) ln collaboration with all genetic resource centers established under any other law, establish a national indigenous gene bank for the preseruation of all indigenous plant and animal varieties, land races and wild relatives.

6.

NEW CLAUSES: lnsert the following new clauses immediately after clause 7 as follows; 5 I 7A.
GOVERNING COUNCIL (1) Thereis esfab/ished a Governing Council which shall be the governing organ of the Council.

(2) The Governing Council consists of- (a) a Chairperson, who shall be a scientist; and (b) four other members who shall be of high moral character, proven integrity and who possess considerable experience and demonstrated competence in the conduct of public affairs.

(3) The members of the Governing Council shall be appointed by the President.
(4) A person shall not be eligible for appointment if such person is an employee or director of any company, firm or institution where such employment or directorship may lead to conflict of interest.

(5) The members of the Governing Council shall hold office on terms and conditions specified in their instruments of appointment.

(6) The President shall, in appointing the members of the Governing Council, ensure that there is a balance of gender, skills and experience.
(7) The members of the Governing Councrl shall be persons of high mora!

character, proven integrity and shall be fit and proper persons.

(8) The Executive Director shall attend the meetings of the Governing Council by virtue of his or her office, but shall not have the right to vote on any matter before the Governing Council.

6 a (9) The Governing Council may appoint Committees of the Governing Council for the efficient operation of the governance function of the Governing Council.

78.
78.

Tenure of office of members of the Governing Council (1 ) A member of the Governing CouncrT, other than the Executive Director, shall hold office for five years and is eligible for reappointment for only one more term.

(2) A member of the Governing Council may, at any time, resign his or her office in writing addressed to the President.
(3) A member of the Governing Council may be removed from office by the President for - (a) inability to perform the functions of his or her office arising from infirmity of body or mind; (b) misbehavior or misconduct; (c) incompetence or conflict of interest; (d) absence, without prior permission of the chairperson, or without reasonable cause to the satisfaction of the President for more than four consecutive meetings of the Governing Council, or absence from Uganda for more than six months; (f) being bankrupt or insolvent or entering into a composition scheme with his or her creditors; or being convicted of a criminal 7 a offence, in Uganda or outside Uganda, in respect of which the maximum penalty exceeds six months imprisonment without the option of a fine.
(5) Where a member of the Governing CouncrT resigns, dies, or is removed from office, the chairperson shall notify the President of the vacancy and the President shall appoint another person to hold the office for the unexpired portion of the member's term of office.
(6) Where the member of the Governing Councl referred to in subsection (5) is the chairperson, the secretary to the Governing Council shall notify the President of the vacancy and the President shall appoint another person, being a member of the Governing Council, to hold office for the unexpired portion of the chairperson's term of office.

(7) Where a member of the Governing Councl is under investigation for an offence involving dishonesty, fraud or moral turpitude, the member shal!
not perform his or her duties as a Governing Council member until investigations are concluded.

7C.

Meetings of the Governing Council (!)

The Governing Council shall meet at least once every three months for the purposes of discharging its functions.

(2) The meetings of the Governing CouncrT shall be conducted in accordance with Schedule 6.

8 7D.

Remuneration of members of the Governing Council.

A member of the Governing Councilshall be paid such allowances determined by the President.

7E.
7E.

Functions of the Governing Council (!

)The Governing Council is responsible for the general direction and supervision of the National Genetic Engineering Council.
(2) For the purpose of subsection (l), the Gove rning Councilshall; (a) monitor and supervise the implementation of this Act; (b)advise the President on all matters in relation to the Act; (c) oversee the operations of the Council; (d)review and approve strategic and operating plans , budgets , reports and financial statement of the Council; (e)establish and approve rules of procedures for appointment, termination, discipline and terms and conditions of staff of the council; and (f) perform any other function incidental to the functions of the Governing Council.
7F.

lndependence of the Gouncil.

Except as provided under this Act or any other law, the Council shall exercise its functions independent of any person or body.

9 7G.

Secretariat of the Gouncil.

Staff of the Council (l) The Council shall establish a Secretariat headed by an Executive Director.

(2) The Governing Council shall appoint the Executive Director and other staff as may be necessary for the proper and efficient discharge of the objects and functions of the Council under this Act.
(3) The Secretariat shall have such other functions as may be assigned to it by the Governing Council.

(a) The remuneration of the Executive Director and all staff shall be determined by the Governing Council.

7H.

Functions of the Executive Director.

(l)The Executive Director shall be the Chief Executive and Accounting Officer of the Council.

(2) The Executive Director sha!!

be responsible for the day to day operations and administration of the Council.
(3) Subject to this Act and to the general supervision and control of the Governing Council, the Executive Director is responsible for- (a) implementing the objectives, policies and programmes of the Council; (b) the proper management of the funds and properties of the Council ; (c) the development of an economic, efficient and cost effective internal management structure; (d) ensure the effective functioning of the Council for the realization of its functions; and 10 (e) performing any other function necessary for the implementation of this Act as may be assigned by the Governing Council.
FINANCES OF THE COUNCIL 7l Funds of the Gouncil (l) The funds of the Council shall consist of; (a) monies appropriated by Parliament for the purposes of the Council; and (b) donations or grants received from sources within or outside Uganda with the approva!

of the Minister responsible for Finance.

7K.

Compliance with the Public Finance Management Act, 2015 The Council shall at all times comply with the Public Finance Management Act, 20/,5.

7L.

Annual Reports The Counci!


shall, of the end of each financial year, submit to the President, an annual report on the operations of the Council during the preceding year, which sha!!

include on audited financial statement.

Justification To align the management of the funds of the Council with the requirements applicable to all entities drawing money from the consolidated fund.

Delete Clause 9 and consequentially the Second Schedule 7.
Justification The lnter-[t/inisterial Committee on biosafety is no longer necessary since the National Genetic Engineering Council is vested under the supervision of the President.

1.1 8.

New clauses lnsert a new clause immediately after clause 13 but under Part lll to read as follows; 13A.

Criteria for decision making.
(1) The Competent Authority shall not grant any approval unless if is safisfied that the release, export, import or transit of genetically engineered material shall- (a) benefit the country without causing risk to human and animal health, non- genetically engineered plants or animals, biological diversity or the environment; (b) contribute to sustainable development; (c) not have adverse socio-economic impacts; and (d) conform to the ethical values and concerns of the communities and does not undermine community knowledge and technologies.
(2) The Competent Authority shall as condition for approval require an applicant to provide a performance bond in the form of insurance covers for performance and obseruance of the obligations under this Act.

Justification The proposed criteria will be essentia!

in addressing among others the concerns in the President's letter (paragraph 1, 4, and 5) regarding protection of indigenous farming practices, prevention of environmental pollution, poisonous and dangerous bacteria.
A new clause on Notification of application for patent.

T2 lnsert a new clause immediately after clause 13A to read as fo!

!ows; 138 Notification of application for a patent.
An applicant for a patent of a genetic engineering technology or genetically engineered material, whether in or outside Uganda, in relation to a genetic resource or traditional knowledge associated with a genetic resource accessed in Uganda shall notify the Competent Authority in writing within thirty days from the date of the application.
Justification To provide an opportunity to the Competent Authority to raise any objections to patenting of genetic engineering technology or genetically engineered materia!

so as to address the concerns related to monopoly of patents, modification of genetic resources and benefit sharing as raised in the President's letter.

(Paragraph 1).

New clause on Access to Genetic Resources and Benefit Sharing lntroduce a new clause immediately after clause 138 13C Access to Genetic Resources and Benefit Sharing.
(1) The power to determine, control and regulate access to natural resources found in Uganda is vested in the Government for the benefit of the people of Uganda.

13 (2) Notwithstanding sub section (1), a person or entity engaging in a genetic engineering activity shall not access genetic resources unless that person or entity has obtained written consent and entered into an accessory agreement with the relevant Iead agency, local community or owner of the genetic resource as the case maybe.
(3) The agreement referred to in sub section (2) shall among others stipulate the market value of the genetic resources which will be determined on a case by case basis by the Competent Authority.

(4) Any benefits and or intellectual property rights accruing to the genetic resources shall be a joint ownership of the developer and local community or owner.

Justification This is more comprehensive and provides an alignment to current law that regulates genetic resources in Uganda.

PART III.
PART III.

RESEARCH AND GENERAT RELEASE OF A GEM 9.

Clause 16.

Approval for each stage of research.

i.

Replace sub clause (2) with the following; (2) The Competent Authority shall, before the approval of any stage of research, require the applicant to obtain written confirmation from the relevant institution on whether the indigenous animal or plant variety is preserued in a national indigenous gene Bank.
!nsert the following new sub clauses immediately after sub clause (2) 1,4 (3) Every sfage of research shall require a biosafety quality certificate issued by the Competent Authority.

(4) The Competent Authority shall establish the criteria and procedures for the requesf, issuance, review, extension, suspension and cancellation of a biosafety quality certificate referred to under sub section (3).
Justification To ensure that the applicant wholesomely and explicitly bears the burden of confirming whether the animal or seed variety under research is preserved in a national indigenous gene bank.

10.

Clause 26.

Labelling of Genetically Engineered Materials.


Amend clause 26 in the headnote as follows, Labelling of Genetically Engineered Materials in sub clause (1) amend as follows; (1) A person involved in the research, development, general release, importation, exportation, transit or trade of GEhtl shall; (a) conspicuously label the GEAI with the words- "Contains Genetically Engineered Material," and (b) indicate the characterisfics and origin of the GEM.
Justification To create traceability of the GEIM and allow regulators to safeguard against harm 15 This provides for a more elaborate labelling to enable consumers make reasonable choices.

11. lnsert a new part immediately after Part lV with the following new clauses; PART IVA.

CO.EXISTENCE A new clause 28A 284. lsolation Measures (1) A person who, i. conducts genetic engineering research whether in a laboratory, or contained facility, or greenhouse, or contained field; or ii.
engages in the production, processrng, transit, import or export of GEM, shall take physical, biological and reproductive measures in accordance with this Act or regulations made under this Act to prevent contamination or mixture of the genetically engineered material with products of organic and conventional agriculture (2) A person who conducts genetic engineering research whether in a laboratory, or contained facility, or greenhouse, or contained field or engages in the production, processrng, transit, import or export of GEAII contrary to the physical, biological and reproductive measures established under this Act or any regulations made under this Act, commits an offence and shall on conviction, be liable to a fine not exceeding five hundred currency points.
16 (3)A person who keeps or owns genetically engineered animals shall prevent any cross-breeding between the genetically engineered and non-genetically engineered animal.

(4)a person who cultivates genetically engineered crops or plants shall prevent any cross-bre eding between the genetically engineered crops or plants and non-genetically engineered plants or crops.
(s)The Atlinister ffiay, in consultation with the Competent Authority, and with the approval of Cabinet declare, for a specified period of time, any part of the country free from the propagation of genetically engineered plants and animals.

(6)A district council, may by resolution, petition the hrlinister to declare for a specified period of time, its area or any part thereof, free from the propagation of genetically engineered plants or animals.
(7)A declaration made in subsections (5) and (6) shall be published in the gazette and newspapers of wide circulations.

(8)A petition referred tn sub-section (6) shall be disposed of within forty five days from the date the petition is submitted to the Atlinister and decision communicated to the Petitioner and Parliament.
(9)The Arlinister shall in consultation with the Competent Authority and with approval of Cabinet by statutory instrument make regulations for isolation measures to prevent any contamination or mixture of 77 $ the genetically engineered material with products of organic and co nve ntio n al ag ricu ltu re.

Justification These are more explicit in addressing the President's concern in paragraph 3 of his letter.

12.

Clause 35 Liability for damages.


Amend clause 35 by replacing as follows; A proprietor or an individual developer of genetically engineered material under this Act shal!

be strictly liable for any damage, harm, inconvenience or loss caused to the community livelihood, indigenous knowledge systems or technologies, environment, biodiversity, ecosystem, species of flora and fauna or human and animal health.
Justification This is one of the clauses that the President referred for reconsideration for which the committee makes no proposed amendment or loss caused by a proprietor or an entity through genetically engineered technologies and materials.

To provide for strict liability for damage, harm, inconvenience.

13.
13.

Clause 36 Rephrase paragraph (f) as follows; 18 (f) deliberately uses a GEt\4 to harm or injure human or animal life or the environment, commits an offence and shall on conviction be liable to life imprisonment.

Justification To clearly establish the mental element in the commission of the crime 14.

A new clause on offences by a body corporate.

lnsert a new clause immediately after clause 36 to read as follows Offences by Bodies corporate.
Where a body corporate is guilty of an offence against this Act, the body corporate shall be liable to the penalties therefor so far as those penalties are capable of being imposed upon a body corporate, and any director manager or officer of the body corporate who knowingly directs, authorizes or suffers the commission of the offence by the body corporate shall, without affecting the liability of the body corporate therefore, be severally guilty of an offence and liable to the penalty or punishment applicable thereto.
Justification This is clearer, and more elaborate 15.

Clause 41.

Amendment of Schedules Replace sub clause (2) as follows; (2) The Minister may on the recommendation of the Competent Authority by Statutory instrument amend the Schedules to this Act.

16.

Clause 42 Regulations 19 Amend in sub clause (2) by inserting a new paragraph immediately after paragraph (g) (h ) prescribing the criteria for access to genetic resources and benefit sharing.

17.
17.

New Schedules lnsert a new schedule 6 immediately after schedule 5 SCHEDULE 6.

MEETINGS OF THE GOVERNING COUNCIL AND RELATED MATTERS l. Meetings of the Governing Council.

(l) The chairperson shall convene every meeting of the Governing Council at a time and place as the Governing Council may determine, and the Governing Council shall meet for the discharge of business at least once in every three months.
(2) The chairperson may, at any time, convene a special meeting of the Governing Council and shall also call a meeting within fourteen days, if requested to do so in writing by two thirds of the members of the Governing Council.

(3) Notice of a meeting of the Governing Counci!

shall be given in writing to each member at least fourteen working days before the day of the meeting.

(a) The chairperson shal!


preside over every meeting of the Governing Council and in his or her absence the members present shall elect from among themselves, a chairperson to preside over the meeting.

2.

Quorum.

(1) The quorum for a meeting of the Governing Council is two thirds of the members.
(2) All decisions of a meeting of the Governing Council shall be by majority of the votes of the members present and voting and in case of equality of votes, the person presiding at the meeting shall have a casting vote in addition to his or her deliberative vote.

20 I 3.

Minutes of meetings.

(l) The secretary shall record and keep, minutes of all meetings of the Governing Council in a form approved by the Governing Council.

(2) The minutes recorded under this paragraph shal!
be submitted to the Governing Council for confirmation and where they are confirmed, shall be signed by the chairperson and the secretary in the presence of the members present of the meeting.

4.

Power to co-opt.

(l) The Governing Council may invite any person who, in the opinion of the Governing Council, has expert knowledge concerning the functions of the Governing Council, to attend and take part in a meeting of the Governing Council.
(2) A person attending a meeting of the Governing Council under this section may take part in any discussion of the meeting in which his or her advice is required, but shall not have a right to vote in that meeting.

5.

Validity of proceedings not affected by vacancy.

The validity of any proceedings of the Governing Council shal!
not be affected by a vacancy in its membership or by any defect in the appointment or qualification of a member or by reason that a person not entitled took part in its proceedings.

6.

Disclosure of interest of members.


(l) A member of the Governing Council who is in any way directly or indirectly interested in a contract made or proposed to be mode by the Governing Council, or in any other matter to be considered by the Governing Council, shall disclose the nature of his or her interest at a meeting of the Governing Council.

(2) A disclosure made under subparagraph (l) shal!

be recorded in the minutes of that meeting.


(3) A member who makes a disclosure under subparagraph (l) shall not be present during any deliberation of the Governing Council with respect to that 2t a matter; or take part in any decision of the Governing Council with respect to that matter.

(4) A member who fails to disclose his or her interest under subparagraph (2) of this paragraph shall be removed from the Governing Council.
(5) For purposes of determining whether there is a quorum, a member withdrawing from a meeting or who is not taking part in a meeting under subparagraph (3) sha!!

be treated as being present.

7.

The Governing Council may regulate its procedure.

Subject to this Act, the Governing Council may regulate its own procedure or any other matter relating to its meetings.

18.
18.

Title Replace the title as follows; "The Genetic Engineering Regulatory Bill" Justification The proposed short title captures the content of the Bill and is in line with the concern of the President.

22 MEMBERS OF THE COMMITTEE ON SCIENCE, TECHNOLOGY AND INNOVATION WHO ASSENTED TO THE HARMONISED POSITION ON THE BILL FOR AN ACT ENTITLED THE NATIONAL BIOSAFETY ACT, 2Ot7 NO NAME PARTY SIGNATURI N -KlrJL, I dsd.

..J,it ------: '/tr Hon.

Bwino Fred Kyakulaga Hon.

Mutebi David Roniie Hon.


Abacacon Angiro Gutomoi Hon.

Aleper Aachila Margaret Hon.

Atuhaire Jacklet Hon.

Buturo Nsaba James Hon.

Ikoio John Bosco Hon.

Kahunde Helen Hon.

Kivinei Deogratius Gonzaga DP Hon.

Oketayot C.D.

Lowila 11 Hon.

Namuiiu Cissy Dionrzia L2 Hon.

Nauwat Rosemary 13 Hon.

Niringriyimana J. Ruugi NRM NRM FDC NRM INDEP NRM NRM NRM NRM NRM NRM NRM Kaberuka 14.

Hon.

Nyiira Zerubabel Miiumbi NRM 15.

Hon.

Okin P. P. Oiara INDEP t6.

Hon.


Sematimba Peter Simon NRM t7.

Hon.

Turvahik"yo Paula Mary NRM 18.

Hon.

Wamala Namboozo Mayoga NRM t9 Hon.

Yaguma Wilberforce pKv\\-